Osteoarthritis, KneeNCT00601497
Effects of Electrical Stimulation on Osteoarthritis of the Knee
A study testing InterX 5000 in people with Osteoarthritis, Knee, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to find out whether electrical stimulation can reduce knee pain and increase function in people with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- InterX 5000
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years of age or older
- Diagnosis of primary osteoarthritis of the knee (as defined by American College of Rheumatology criteria)
- Knee pain of at least six months duration
- Moderate or greater knee pain (defined as a score of 3 or greater on an 11 point numeric pain rating scale) for most days in the last month
- Willing to abide by protocol and treatment schedule.
Who cannot join
- Implants, such as pacemaker, TENS, or insulin pump, incompatible with electrical stimulation
- Uncontrolled concomitant disease affecting the knee, such as: rheumatoid arthritis, systemic lupus erythema, psoriatic arthritis
- Pregnant or breast-feeding
- Intra-articular corticosteroid or hyaluronic acid injection into the knee within 3 months preceding study
- Arthroscopy of the knee within the past year
- Significant injury to the knee within the past 6 months
- Use of assistive devices other than a cane or knee brace
- Disease of spine or other lower extremity joints of sufficient degree to affect assessment of the knee
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
The purpose of this study is to find out whether electrical stimulation can reduce knee pain and increase function in people with osteoarthritis of the knee.
- Conditions
- Osteoarthritis, Knee
- Being tested
- InterX 5000
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterX 5000Device
Also called Noninvasive Interactive Neurostimulation
20-30 minute device sessions on the following schedule: 3 times per week for 3 weeks, then 2 times per week for 3 weeks, then 1 time per week for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: InterX 5000 |
| 2 | Placebo comparator | Not described Receives: Device: InterX 5000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Pain
Measured: Baseline, Week 4, Week 8, and Week 12
Secondary outcomes (4)
Knee function
Measured: Baseline, Week 4, Week 8, and Week 12
Knee stiffness
Measured: Baseline, Week 4, Week 8, and Week 12
Patient global assessment
Measured: Baseline, Week 4, Week 8, and Week 12
Health-related quality of life
Measured: Baseline, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startDec 2004
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- Ann G Taylor, RN, EdD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601497
- Sponsor's protocol ID
- HIC 11630
- Status last verified
- Jan 2008
- First submitted
- 12 Jan 2008
- Last updated
- 28 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electrical Stimulation on Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00601497
- Acronym / sponsor ID
- HIC 11630
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out whether electrical stimulation can reduce knee pain and increase function in people with osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: InterX 5000 |
| 2 | Placebo comparator | Device: InterX 5000 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50 years of age or older
- Diagnosis of primary osteoarthritis of the knee (as defined by American College of Rheumatology criteria)
- Knee pain of at least six months duration
- Moderate or greater knee pain (defined as a score of 3 or greater on an 11 point numeric pain rating scale) for most days in the last month
- Willing to abide by protocol and treatment schedule.
Key exclusion criteria (8 listed)
- Implants, such as pacemaker, TENS, or insulin pump, incompatible with electrical stimulation
- Uncontrolled concomitant disease affecting the knee, such as: rheumatoid arthritis, systemic lupus erythema, psoriatic arthritis
- Pregnant or breast-feeding
- Intra-articular corticosteroid or hyaluronic acid injection into the knee within 3 months preceding study
- Arthroscopy of the knee within the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterX 5000Also: Noninvasive Interactive Neurostimulation20-30 minute device sessions on the following schedule: 3 times per week for 3 weeks, then 2 times per week for 3 weeks, then 1 time per week for 2 weeks. | Device | 1, 2 |
Primary outcome
Knee Pain
Time frame: Baseline, Week 4, Week 8, and Week 12
4 secondary outcomes
Knee function
Time frame: Baseline, Week 4, Week 8, and Week 12
Knee stiffness
Time frame: Baseline, Week 4, Week 8, and Week 12
Patient global assessment
Time frame: Baseline, Week 4, Week 8, and Week 12
Health-related quality of life
Time frame: Baseline, Week 4, Week 8, and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann G Taylor, RN, EdD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InterX 5000 in people with Osteoarthritis, Knee, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Pain (time frame: Baseline, Week 4, Week 8, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2008.